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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K813411
Device Name DOCUMENT LINEARITY TEST STANDARDS
Applicant
North American Standards
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
North American Standards
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1150
Classification Product Code
JIX  
Date Received12/04/1981
Decision Date 12/18/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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